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T138067 Versus Doxorubicin in Chemotherapy-Naive, Unresectable, Hepatocellular Carcinoma Patients

This study has been terminated.
Information provided by:
Tularik Identifier:
First received: March 31, 2003
Last updated: June 23, 2005
Last verified: September 2004
This is an international, multicenter, randomized study of intravenous T138067 versus intravenous doxorubicin in hepatocellular carcinoma (liver cancer). Patients can not have been treated before with chemotherapy and surgery is not recommended for their cancer. A total of 750 subjects will be enrolled in this study.

Condition Intervention Phase
Hepatocellular Carcinoma Drug: T138067 intravenous Drug: doxorubicin intravenous Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Tularik:

Estimated Enrollment: 750
Study Start Date: March 2003

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Key inclusion criteria include:

  • pathologic diagnosis of unresectable HCC
  • chemotherapy-naïve for HCC
  • Child-Pugh Class A or B liver disease
  • measurable disease (i.e., at least one lesion that is at least 20 mm in one dimension) on computerized tomography (CT) scan or magnetic resonance imaging (MRI) or at least one lesion that is at least 10 mm on spiral CT scan
  • Karnofsky Performance Status of ≥ 70%
  • life expectancy of ≥ 12 weeks
  • adequate hematologic function (i.e., absolute neutrophil count [ANC] of ≥ 1500 cells/mm3, platelet count of ≥ 80,000 cells/mm3, hemoglobin of ≥ 8.5 g/dL)
  • total bilirubin of ≤ 1.5 upper limit of normal (ULN)
  • aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 5 ULN
  • serum creatinine of ≤ 2 x ULN

Key exclusion criteria include:

  • severe, concurrent disease that would make the subject inappropriate for enrollment
  • Subjects who have received prior intravenous or intra-arterial chemotherapy, chemoembolization, intratumoral ethanol injection, cryosurgery, radiofrequency ablation, or embolization for their HCC. (note: prior surgical resection, immunotherapy, hormonal therapy, radiotherapy, and/or orthotopic liver transplantation are allowed)
  • history of other cancer within the past 5 years other than adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix
  • New York Heart Association (NYHA) class III or IV heart disease or a left ventricular ejection fraction of <50% or acute anginal symptoms
  • females who are pregnant or breast-feeding
  • received any investigational agent within 4 weeks of enrollment
  • history of central nervous system metastases or carcinomatous meningitis
  • clinically apparent ascites
  • major surgery within 4 weeks of study enrollment
  Contacts and Locations
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Please refer to this study by its identifier: NCT00057382

  Show 76 Study Locations
Sponsors and Collaborators
Study Director: Mohammad Hirmand, MD Tularik
  More Information Identifier: NCT00057382     History of Changes
Obsolete Identifiers: NCT00066287
Other Study ID Numbers: T-067-010
Study First Received: March 31, 2003
Last Updated: June 23, 2005

Keywords provided by Tularik:
liver cancer

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on August 22, 2017